To meet the urgent clinical needs of patients, regulatory agencies have established special designations and accelerated pathways within their regulatory frameworks to expedite drug development and market approval. Applying for special designations and accelerated pathways at the appropriate time based on the characteristics of the drug, therapeutic area, and existing data can significantly reduce development costs, shorten time to market, and increase the success rate of regulatory approval. Taking the FDA as an example, in 2022, out of the 37 new drugs approved by CDER, 24 (65%) received at least one accelerated designation such as Fast Track, Breakthrough Therapy, Priority Review, or Accelerated Approval, and 20 (54%) were granted orphan drug designation (ODD). Some important special designations and accelerated pathways include:
FDA
>Fast Track Designation
>Breakthrough Therapy Designation
>Accelerated Approval
>Priority Review
>Regeneration Medicine Advanced Therpapy (RMAT)
>Orphan Drug Designation (ODD)
>Rare Pediatric Disease Designation (RPDD)
>Qualified Infectious Disease Product (QIDP) Designation
>Special Protocol Assessment (SPA)
>Real-Time Oncology Review (RTOR)
NMPA
>NMPA Breakthrough Therapy Program
>Conditional Approval Program
>Priority Review and Approval Program
>Special Review Program
Humphries's expert team has extensive experience and is particularly skilled in handling various types of pathways and designation applications, providing comprehensive support to Sponsors. Here are the specific services we offer:
01. Development of Application Strategy
Humphries customizes the application plan for special designations and accelerated pathways based on the client's product type, characteristics, indications, development stage, and non-clinical/clinical data. We estimate the timeline, budget, and key milestones to ensure a smooth application process.
02. Feasibility and Gap Analysis
Humphries is proficient in the application processes and evaluation criteria for different pathways and designations. We can assess the gap between the client's existing data and the application goals and assist in developing solutions to ensure the information fully supports the application.
03. Writing or Reviewing Application Materials
Humphries drafts the relevant application materials based on the client's provided raw data. Additionally, we can review materials prepared by the client to ensure completeness, accuracy, readability, and compliance with specific designation standards.
04. Representation in Communication with Regulatory Agencies
For certain pathway applications, such as the Breakthrough Therapy designation, which have a relatively high rejection rate, active communication with regulatory agencies is essential. During the application process, applicants need to maintain positive communication, such as through telephone conferences or written correspondence, to clarify issues, address doubts, and ultimately reach a consensus. Humphries's consultants have extensive experience and skills in communicating with regulatory agencies, maximizing the Sponsor's benefits.
05. Continuous Project Management and Maintenance
Once the application is approved, Humphries continues to provide regulatory support, ensuring compliance with specific requirements from regulatory agencies during subsequent development and approval processes, ensuring the smooth progress of the project.
